ArQule Fails in Colorectal Cancer Trials

ArQule Inc. (NASDAQ: ARQL) is about to lose some serious hope for investors. It and Daiichi Sankyo announced that the top-line results of phase 2 trial with tivantinib in colorectal cancer did not meet the primary endpoint of progression-free survival. This was its randomized Phase II signal generation trial of tivantinib used in combination with irinotecan and cetuximab for patients who suffered from refractory or relapsed colorectal cancer.

The company said that while the trial did not meet its primary endpoint of progression-free survival (PFS), the analysis of the patients enrolled did rise slightly. Its median PFS was 8.3 months in the experimental arm. versus 7.3 months in the control arm. ArQule’s objective response rate (ORR) was a secondary endpoint and that was 45% in the experimental arm, versus 33% in the control arm. This was said to be not statistically significant.

What ArQule has said is that the PFS results obtained in both the control arm and the experimental arm were longer than expected based on previously published historical norms. It also said that tivantinib in combination with irinotecan and cetuximab shows a trend of prolonged progression free survival and improved objective response rate in signal generation trial. Unfortunately this was not enough of a boost.

ArQule shares were trading down 20% at $2.33, against a 52-week range of $1.98 to $8.32. Before the fiasco, the company’s market cap was $182 million. Its net tangible asset value was $85.37 milliion as of the end of September, but at the same time its cash, short-term and long-term securities were listed as almost $140 million combined. Unfortunately the image below of its pipeline shows that tivantinib is the lead product candidate.